Pharmacist-Led Follow-Up Program for Rural Patients with Acute Coronary Syndrome: The PLURAL-ACS Pilot Program.

Background: Patients living in rural settings have poorer access to care and more frequent readmissions after treatment for acute coronary syndrome (ACS) than patients in urban settings. It is unclear what types of medication-related issues are encountered by this cohort and whether pharmacist-led care could resolve them. Objectives: To describe the issues related to cardiac medications encountered by rural patients after treatment for ACS and the impact of a pharmacist-led virtual follow-up pilot program in this population. Methods: A quality improvement initiative was developed whereby a cardiology pharmacist provided follow-up to post-ACS rural patients in Alberta, Canada, between March and May 2022. For each patient, the pharmacist identified and resolved cardiac medication-related issues through regular telephone visits over a 30-day period following hospital discharge. The primary outcome was the number of cardiac medication-related issues identified. Secondary outcomes included the types of medication-related issues identified and actions taken by the pharmacist to resolve them. Results: During the 15-week program, 40 patients received care, and 139 virtual visits were completed. The median time spent per visit was 60 (interquartile range [IQR] 50-80) minutes. In total, 255 cardiac medication-related issues (6 per patient, IQR 3.75-8.25) were identified, of which 233 (91%) were resolved by the pharmacist. Prescription errors, adverse effects, and drug therapy optimization were the most common issues identified on days 1, 10, and 30, respectively. The pharmacist commonly undertook patient counselling (n = 126, 54%) and medication prescribing (n = 63, 27%) to address medication-related issues. Conclusions: A substantial number of cardiac medication-related issues were identified and resolved through a pharmacist-led virtual follow-up program in rural post-ACS patients. These findings could assist in the development of future follow-up programs to improve care for this high-risk population.

Contexte: L'accès des patients vivant en milieu rural aux soins est plus difficile et leur réadmission plus fréquente après un traitement pour le syndrome coronarien aigu (SCA) que les patients vivant en milieu urbain. On ne sait pas exactement quels types de problèmes liés aux médicaments rencontre cette cohorte et si les soins dispensés par les pharmaciens pourraient les résoudre. Objectifs: Décrire les problèmes liés aux médicaments cardiaques que rencontrent les patients vivant en milieu rural après un traitement pour le SCA et les effets d'un programme pilote de suivi virtuel dirigé par un pharmacien dans cette population. Méthodes: Une initiative d'amélioration de la qualité a été développée dans le cadre de laquelle un pharmacien en cardiologie a assuré le suivi des patients vivant en milieu rural après un SCA en Alberta, au Canada, entre mars et mai 2022. Pour chaque patient, le pharmacien a identifié et résolu les problèmes liés aux médicaments cardiaques grâce à des visites téléphoniques régulières sur une période de 30 jours après le congé de l'hôpital. Le critère de jugement principal était le nombre de problèmes identifiés liés aux médicaments cardiaques. Les critères de jugement secondaires comprenaient les types de problèmes liés aux médicaments identifiés et les mesures prises par le pharmacien pour les résoudre. Résultats: Au cours du programme de 15 semaines, 40 patients ont reçu des soins et 139 visites virtuelles ont été réalisées. La durée médiane de chaque visite était de 60 minutes (intervalle interquartile [IQR] 50­80). Au total, 255 problèmes liés aux médicaments cardiaques (6 par patient, IQR 3,75­8,25) ont été identifiés, dont 233 (91 %) ont été résolus par le pharmacien. Les erreurs de prescription, les événements indésirables et l'optimisation du traitement médicamenteux étaient les problèmes les plus fréquents les jours 1, 10 et 30, respectivement. Le pharmacien offrait généralement du counseling aux patients (n = 126, 54 %) et prescrivait des médicaments (n = 63, 27 %) pour résoudre les problèmes liés aux médicaments. Conclusions: Un nombre important de problèmes liés aux médicaments cardiaques ont été identifiés et résolus grâce à un programme de suivi virtuel dirigé par un pharmacien chez les patients vivant en milieu rural après un SCA. Ces résultats pourraient aider à élaborer de futurs programmes de suivi pour améliorer les soins dans cette population à haut risque.

Anticoagulant Prescribing Patterns in New-Onset Atrial Fibrillation After Cardiac Surgery.

BACKGROUND: Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery and is associated with an increased risk of thromboembolic stroke. Recommendations regarding the optimal anticoagulant, timing of initiation, and duration of therapy remain uncertain. METHODS: Administrative databases were used to include adult patients who presented with POAF after cardiac surgery between January 1, 2015, and December 31, 2020. Key exclusion criteria included preexisting atrial fibrillation, mechanical valve replacement, or anticoagulant prescription fill within 6 months before the index admission. RESULTS: A total of 3214 of patients were included, and 878 (27.3%) were prescribed an oral anticoagulant (OAC) on discharge, with 536 (61%) prescribed warfarin and 342 (39%) prescribed a direct OAC. More than half of the patients (56.1%) stopped their OAC by 6 months. There was no difference in stroke or systemic embolism at 30 days, 3 months, or 6 months between those with and without anticoagulation prescribed. However, those on any OAC had higher rates of any bleeding at all time points. CONCLUSIONS: A minority of patients who presented with POAF after cardiac surgery were prescribed OAC, with warfarin being the most common agent. OAC initiation was associated with increased bleeding risk, warranting special consideration when assessing a patient's risk of stroke with the increased risk of bleeding, particularly in the postoperative period.

Direct oral anticoagulants for atrial fibrillation in early postoperative valve repair or bioprosthetic replacement.

OBJECTIVE: Despite increased use of direct oral anticoagulants (DOACs), limited evidence guides their use in the early postoperative period after bioprosthetic valve implantation in patients with atrial fibrillation. Our objective was to describe the efficacy and safety of DOACs and warfarin in the first 3 months after surgical bioprosthetic valve replacement or repair in patients with atrial fibrillation. METHODS: This was a retrospective, registry-informed cohort study of surgical patients who underwent bioprosthetic valve replacement or repair, had concomitant atrial fibrillation and received oral anticoagulation at discharge. The primary efficacy outcome was a composite of death, ischemic stroke, transient ischemic attack, and systemic embolism; the primary safety outcome was a composite of major bleeding. Key secondary outcomes were comparative analyses of primary outcomes, temporal anticoagulation prescribing patterns, and 30-day readmission rates. RESULTS: A total of 1743 patients were included. Of the 570 patients in the DOAC group, 17 (2%) met the composite efficacy outcome and 55 (10%) met the composite safety outcome. Of the 1173 patients receiving warfarin, 41 (3%) and 114 (10%) met the composite efficacy and safety outcomes, respectively. Comparative secondary analysis was not statistically significant for either the efficacy (adjusted odds ratio, 0.85; 95% confidence interval, 0.46-1.55, P = .59) or safety (adjusted odds ratio, 0.94; 95% confidence interval, 0.66-1.34, P = .76) outcomes. The 30-day readmission rates were similar between both groups. CONCLUSIONS: Our results suggest DOACs may be safe and effective alternatives to warfarin in the early postoperative period after valve repair or surgical bioprosthetic replacement. Confirmation awaits adequately powered prospective studies.

Evaluation of Online Written Medication Educational Resources for People Living With Heart Failure.

Background: Patient educational resources on heart failure (HF) medications may improve patient understanding, which is critical for informed decision-making and patient self-efficacy. The purpose of our study was to evaluate the quality and readability of written medication educational resources available online. Methods: Two investigators searched Google, Yahoo, and Bing for written patient educational resources that addressed at least one HF medication. We assessed educational quality using the Ensuring Quality Information for Patients (EQIP) tool (range 0 [worst] to 100 [best]), and we evaluated readability using the Flesch-Kincaid Grade Level. Results: From 693 identified webpages, 39 HF medication educational resources met study eligibility. Among included resources, the median Ensuring Quality Information for Patients score was 61% (interquartile range 54%-68%), with 2 (5%) rated as high quality (score ≥ 75%). The median Flesch-Kincaid Grade Level was 8 (interquartile range 8-12), with 4 (10%) resources meeting the recommended 6th-grade reading level. Conclusions: Most HF medication educational resources available on the Internet are of acceptable educational quality, but could readily be improved. Most resources were beyond the recommended reading grade level for educational resources, limiting their utility for patients with a low literacy level.

Contexte: Les ressources éducatives destinées aux patients au sujet des médicaments contre l'insuffisance cardiaque (IC) pourraient améliorer la compréhension des patients, ce qui est essentiel pour la prise de décisions éclairées et pour le sentiment d'autoefficacité des patients. L'objectif de notre étude était d'évaluer la qualité et la lisibilité des ressources médicales éducatives écrites en ligne. Méthodologie: Deux membres de l'équipe de recherche ont utilisé Google, Yahoo et Bing pour repérer les ressources éducatives écrites destinées aux patients et portant sur au moins un médicament contre l'IC. La qualité éducative des ressources a été évaluée avec l'outil « Ensuring Quality Information for Patients ¼ (EQIP), qui fournit avec un score allant de 0 (pire) à 100 (meilleur), et la lisibilité a été évaluée avec le test « Flesch-Kincaid Grade Level ¼. Résultats: Sur 693 pages Web repérées, 39 ressources éducatives sur les médicaments contre l'IC répondaient aux critères de notre étude. Pour les ressources évaluées, le score médian sur l'échelle EQIP était de 61 % (intervalle interquartile de 54 % à 68 %), et deux d'entre elles (5 %) ont obtenu un score indiquant une qualité élevée (score ≥ 75 %). Le résultat médian au test Flesch-Kincaid Grade Level était de 8 années de scolarité (intervalle interquartile de 8 à 12), et quatre ressources (10 %) respectaient le niveau de lecture recommandé, qui correspond à une 6e année de scolarité. Conclusions: La plupart des ressources éducatives en ligne sur les médicaments contre l'IC sont d'une qualité éducative acceptable, mais des améliorations sont possibles. La plupart des ressources corres-pondent à un niveau de lecture plus élevé que ce qui est recommandé pour la rédaction de ressources éducatives, ce qui limite leur utilité pour les patients qui ont un faible niveau de littératie.

P2Y12 inhibitor adherence trajectories in patients with acute coronary syndrome undergoing percutaneous coronary intervention: prognostic implications.

AIMS: Post-acute coronary syndrome (ACS) P2Y12 inhibitor non-adherence is common and associated with greater risk of major adverse cardiovascular events (MACEs). Non-adherence can follow different trajectories from an inability to initiate, implement, or continue therapy for the intended duration. We aimed to evaluate P2Y12 inhibitor adherence trajectories among ACS patients treated with percutaneous coronary intervention (PCI), their frequency, and association with MACE. METHODS AND RESULTS: We conducted a cohort study of adults discharged alive after PCI for ACS (2012-16) using the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry linked with administrative data. The primary outcome was P2Y12 inhibitor adherence trajectory in the year after PCI assessed using group-based trajectory modelling. We used logistic regression and Cox proportional-hazards regression to assess associations of trajectories with risk factors and MACE, respectively. We included 12 844 patients (mean age 62.4 years, 23.6% female). Five trajectories were identified: early consistent non-adherence (11.0%), rapid decline (7.7%), delayed initiation (6.0%), gradual decline (20.5%), and persistent adherence (54.8%). Compared with persistent adherence, rapid decline [hazard ratio (HR) 1.23, 95% confidence interval (CI) 1.01-1.49] and delayed initiation (HR 1.41, 95% CI 1.12-1.78) were associated with higher MACE in the overall cohort, whereas early consistent non-adherence was associated with higher MACE only in the subgroup receiving a drug-eluting stent (HR 2.44, 95% CI 1.60-3.71). CONCLUSION: After PCI for ACS, patients followed one of five distinct P2Y12 inhibitor adherence trajectories. Rapid decline and delayed initiation were associated with a higher risk of MACE, whereas early consistent non-adherence was only associated with higher MACE risk in patients with a drug-eluting stent.

Cardiac and cardiometabolic phenotyping of trastuzumab-mediated cardiotoxicity: a secondary analysis of the MANTICORE trial.

AIMS: An improved understanding of the pathophysiology of trastuzumab-mediated cardiotoxicity is required to improve outcomes of patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. We aimed to characterize the cardiac and cardiometabolic phenotype of trastuzumab-mediated toxicity and potential interactions with cardiac pharmacotherapy. METHODS AND RESULTS: This study was an analysis of serial magnetic resonance imaging (MRI) and circulating biomarker data acquired from patients with HER2-positive early-stage breast cancer participating in a randomized-controlled clinical trial for the pharmaco-prevention of trastuzumab-associated cardiotoxicity. Circulating biomarkers (B-type natriuretic peptide, troponin I, MMP-2 and -9, GDF-15, neuregulin-1, and IGF-1) and MRI of cardiac structure and function and abdominal fat distribution were acquired prior to trastuzumab, post-cycle 4 and post-cycle 17. Ninety-four participants (51 ± 8 years) completed the study with 30 on placebo, 33 on perindopril, and 31 on bisoprolol. Post-cycle 4, global longitudinal strain deteriorated from baseline in both placebo (+2.0 ± 2.7%, P = 0.002) and perindopril (+0.9 ± 2.5%, P = 0.04), but not with bisoprolol (-0.2 ± 2.1%, P = 0.55). In all groups combined, extracellular volume fraction and GDF-15 increased post-cycle 4 (+1.3 ± 4.4%, P = 0.004; +130 ± 150%, P ≤ 0.001, respectively). However, no significant change in troponin I was detected throughout trastuzumab. In all groups combined, visceral and intermuscular fat volume increased post-cycle 4 (+7 ± 17%, P = 0.02, +8 ± 23%, P = 0.02, respectively), while muscle volume and IGF-1 decreased from post-cycle 4 to 17 (-2 ± 10%, P = 0.008, -18 ± 28%, P < 0.001, respectively). CONCLUSION: Trastuzumab results in impaired cardiac function and early myocardial inflammation. Trastuzumab is also associated with deleterious changes to the cardiometabolic phenotype which may contribute to the increased cardiovascular risk in this population.

The evidence for pharmacist care in outpatients with heart failure: a systematic review and meta-analysis.

AIMS: Patients with heart failure (HF) have poor outcomes, including poor quality of life, and high morbidity and mortality. In addition, they have a high medication burden due to the multiple drug therapies now recommended by guidelines. Previous reviews, including studies in hospital settings, provided evidence that pharmacist care improves outcomes in patients with HF. Because most HF is managed outside of hospitals, we aimed to synthesize the evidence for pharmacist care in outpatients with HF. METHODS AND RESULTS: We conducted a systematic literature search in PubMed of randomized controlled trials (RCTs) and integrated the evidence on patient outcomes in a meta-analysis. We found 24 RCTs performed in 10 countries, including 8029 patients. The data revealed consistent improvements in medication adherence (independent of the measuring instrument) and knowledge, physical function, and disease and medication management. Sixteen RCTs were included in meta-analyses. Differences in all-cause mortality (odds ratio (OR) = 0.97 [95% CI, 0.84-1.12], Q-statistic, P = 0.49, I2  = 0%), all-cause hospitalizations (OR = 0.86 [0.73-1.03], Q-statistic, P = 0.01, I2  = 45.5%), and HF hospitalizations (OR = 0.89 [0.77-1.02], Q-statistic, P = 0.11, I2  = 0%) were not statistically significant. We also observed an improvement in the standardized mean difference for generic quality of life of 0.75 ([0.49-1.01], P < 0.01), with no indication of heterogeneity (Q-statistic, P = 0.64; I2  = 0%). CONCLUSIONS: Results indicate that pharmacist care improves medication adherence and knowledge, symptom control, and some measures of quality of life in outpatients with HF. Given the increasing complexity of guideline-directed medical therapy, pharmacists' unique focus on medication management, titration, adherence, and patient teaching should be considered part of the management strategy for these vulnerable patients.

CCS/CHFS Heart Failure Guidelines Update: Defining a New Pharmacologic Standard of Care for Heart Failure With Reduced Ejection Fraction.

In this update of the Canadian Cardiovascular Society heart failure (HF) guidelines, we provide comprehensive recommendations and practical tips for the pharmacologic management of patients with HF with reduced ejection fraction (HFrEF). Since the 2017 comprehensive update of the Canadian Cardiovascular Society guidelines for the management of HF, substantial new evidence has emerged that has informed the care of these patients. In particular, we focus on the role of novel pharmacologic therapies for HFrEF including angiotensin receptor-neprilysin inhibitors, sinus node inhibitors, sodium glucose transport 2 inhibitors, and soluble guanylate cyclase stimulators in conjunction with other long established HFrEF therapies. Updated recommendations are also provided in the context of the clinical setting for which each of these agents might be prescribed; the potential value of each therapy is reviewed, where relevant, for chronic HF, new onset HF, and for HF hospitalization. We define a new standard of pharmacologic care for HFrEF that incorporates 4 key therapeutic drug classes as standard therapy for most patients: an angiotensin receptor-neprilysin inhibitor (as first-line therapy or after angiotensin converting enzyme inhibitor/angiotensin receptor blocker titration); a ß-blocker; a mineralocorticoid receptor antagonist; and a sodium glucose transport 2 inhibitor. Additionally, many patients with HFrEF will have clinical characteristics for which we recommended other key therapies to improve HF outcomes, including sinus node inhibitors, soluble guanylate cyclase stimulators, hydralazine/nitrates in combination, and/or digoxin. Finally, an approach to management that integrates prioritized pharmacologic with nonpharmacologic and invasive therapies after a diagnosis of HFrEF is highlighted.

Use of low-dose acetylsalicylic acid for cardiovascular disease prevention: A practical, stepwise approach for pharmacists.

Low-dose acetylsalicylic acid (ASA) is recommended in patients with established cardiovascular disease. However, the role of ASA in those without cardiovascular disease (i.e., primary prevention) is less clear, which has led to discordance among Canadian guidelines. In 2018, 3 double-blind, randomized controlled trials were published that evaluated ASA 100 mg daily versus placebo in patients without established cardiovascular disease. In the ASPREE trial, ASA did not reduce the risk of all-cause death, dementia, or persistent physical disability in patients ≥70 years of age but increased the risk of major bleeding. In the ARRIVE trial, ASA failed to lower the risk of a composite of cardiovascular events but increased any gastrointestinal bleeding in patients at intermediate risk of cardiovascular disease. In the ASCEND trial, ASA significantly reduced the primary composite cardiovascular outcome in patients with diabetes for a number needed to treat of 91 over approximately 7.4 years. Yet major bleeding was increased with ASA for a number needed to harm of 112. Therefore, in most situations, ASA should not be recommended for primary cardiovascular prevention. However, there are additional indications for ASA beyond cardiovascular disease. Thus, a sequential algorithm was developed based on contemporary evidence to help pharmacists determine the suitability of ASA in their patients and play an active role in educating their patients about the potential benefits (or lack thereof) and risks of ASA. Can Pharm J (Ott) 2020;153:xx-xx.

The Status of Specialized Ambulatory Heart Failure Care in Canada: A Joint Canadian Heart Failure Society and Canadian Cardiovascular Society Heart Failure Guidelines Survey.

This joint Canadian Heart Failure Society and the CCS Heart Failure guidelines report has been developed to provide a pan-Canadian snapshot of the current state of clinic-based ambulatory heart failure (HF) care in Canada with specific reference to elements and processes of care associated with quality and high performing health systems. It includes the viewpoints of persons with lived experience, patient care providers, and administrators. It is imperative to build on the themes identified in this survey, through engaging all health care professionals, to develop integrated and shared care models that will allow better patient outcomes. Several patient and organizational barriers to care were identified in this survey, which must inform the development of regional care models and pragmatic solutions to improve transitions for this patient population. Unfortunately, we were unsuccessful in incorporating the perspectives of primary care providers and internal medicine specialists who provide the majority of HF care in Canada, which in turn limits our ability to comment on strategies for capacity building outside the HF clinic setting. These considerations must be taken into account when interpreting our findings. Engaging all HF care providers, to build on the themes identified in this survey, will be an important next step in developing integrated and shared care models known to improve patient outcomes.

Ce rapport conjoint des lignes directrices de la Société canadienne d'insuffisance cardiaque et de la Société canadienne de cardiologie (SCC) sur l'insuffisance cardiaque a été élaboré pour fournir un aperçu pancanadien de l'état actuel des soins ambulatoires de l'insuffisance cardiaque (IC) en clinique au Canada, en se référant spécifiquement aux éléments et aux processus de soins associés à des systèmes de santé très performants et de qualité. Il comprend les points de vue de personnes ayant une expérience vécue de l'IC, de prestataires de soins aux patients et d'administrateurs. Il est impératif de s'appuyer sur les thématiques identifiées dans cette enquête, en y engageant tous les professionnels de la santé, pour développer des modèles de soins intégrés et partagés qui permettront de meilleurs pronostics pour les patients. Plusieurs obstacles relatifs aux patients et organisationnels dont il faudra se soucier ont été identifiés dans cette enquête, qui doit servir de base à l'élaboration de modèles de soins régionaux et de solutions pragmatiques pour améliorer les transitions pour cette population de patients. Malheureusement, nous n'avons pas réussi à intégrer les points de vue des prestataires de soins primaires et des spécialistes en médecine interne qui fournissent la majorité des soins en IC au Canada, ce qui limite notre capacité à commenter les stratégies de renforcement des capacités en dehors du cadre des cliniques d'IC. Ces considérations doivent être prises en compte lors de l'interprétation de nos conclusions. L'engagement de tous les prestataires de soins de santé en IC à s'appuyer sur les thématiques identifiées dans cette enquête constituera une prochaine étape importante dans le développement de modèles de soins intégrés et partagés connus pour améliorer le pronostic des patients.

CCS/CHFS Heart Failure Guidelines: Clinical Trial Update on Functional Mitral Regurgitation, SGLT2 Inhibitors, ARNI in HFpEF, and Tafamidis in Amyloidosis.

In this update, we focus on selected topics of high clinical relevance for health care providers who treat patients with heart failure (HF), on the basis of clinical trials published after 2017. Our objective was to review the evidence, and provide recommendations and practical tips regarding the management of candidates for the following HF therapies: (1) transcatheter mitral valve repair in HF with reduced ejection fraction; (2) a novel treatment for transthyretin amyloidosis or transthyretin cardiac amyloidosis; (3) angiotensin receptor-neprilysin inhibition in patients with HF and preserved ejection fraction (HFpEF); and (4) sodium glucose cotransport inhibitors for the prevention and treatment of HF in patients with and without type 2 diabetes. We emphasize the roles of optimal guideline-directed medical therapy and of multidisciplinary teams when considering transcatheter mitral valve repair, to ensure excellent evaluation and care of those patients. In the presence of suggestive clinical indices, health care providers should consider the possibility of cardiac amyloidosis and proceed with proper investigation. Tafamidis is the first agent shown in a prospective study to alter outcomes in patients with transthyretin cardiac amyloidosis. Patient subgroups with HFpEF might benefit from use of sacubitril/valsartan, however, further data are needed to clarify the effect of this therapy in patients with HFpEF. Sodium glucose cotransport inhibitors reduce the risk of incident HF, HF-related hospitalizations, and cardiovascular death in patients with type 2 diabetes and cardiovascular disease. A large clinical trial recently showed that dapagliflozin provides significant outcome benefits in well treated patients with HF with reduced ejection fraction (left ventricular ejection fraction ≤ 40%), with or without type 2 diabetes.

Association of Ticagrelor vs Clopidogrel With Major Adverse Coronary Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.

Importance: Guidelines currently recommend ticagrelor over clopidogrel for patients with acute coronary syndrome (ACS) based on randomized clinical trial data in which ticagrelor reduced major adverse coronary events (MACE) vs clopidogrel but increased bleeding and dyspnea. Objective: To compare the risk of MACE with ticagrelor vs clopidogrel in patients with ACS treated with percutaneous coronary intervention (PCI), to compare major bleeding and dyspnea, and to evaluate the association between P2Y12 inhibitor adherence and MACE. Design, Setting, and Participants: Population-based cohort study using data of patients discharged alive after PCI for ACS from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry from April 1, 2012, to March 31, 2016, with follow-up to 1 year. Analysis began April 2018. Exposures: Outpatient prescription for ticagrelor or clopidogrel within 31 days after PCI. Adherence was defined as a medication refill adherence value of 80% or higher. Main Outcomes and Measures: Major adverse coronary events, a composite of all-cause death, hospitalization for ACS, unplanned coronary revascularization, or stent thrombosis within 365 days after index PCI. Secondary outcomes included hospitalization for major bleeding and emergency department visit for dyspnea. Results: Of 11 185 individuals who underwent PCI, the median (interquartile range) age was 61 (54-71) years, and 2760 (24.7%) were women. Ticagrelor users (4076 [36.4%]) were generally younger and had fewer cardiac and noncardiac comorbidities than clopidogrel users. Ticagrelor was not associated with lower risk of MACE (adjusted hazard ratio [aHR], 0.97; 95% CI, 0.85-1.10); however, it was associated with an increased risk of major bleeding (aHR, 1.51; 95% CI, 1.29-1.78) and dyspnea (aHR, 1.98; 95% CI, 1.47-2.65). A total of 3328 ticagrelor users (81.6%) were adherent during the study vs 5256 of clopidogrel users (73.9%) (P < .001; χ2 = 86.4). In the full cohort, adherence was associated with a lower MACE risk (aHR, 0.79; 95% CI, 0.69-0.90 for adherence of ≥80% vs <80%). Differences in other secondary outcomes were not statistically significant. Sensitivity and subgroup analyses were consistent with primary analyses. Conclusions and Relevance: In this population-based cohort study of patients with ACS who underwent PCI, outpatient use of ticagrelor was not associated with a statistically significant reduction in MACE vs clopidogrel; however, it was associated with more major bleeding and dyspnea.

Anticoagulant therapies and outcomes in obese patients with acute venous thromboembolism.

BACKGROUND: Direct oral anticoagulants (DOACs) are recommended in preference to traditional anticoagulants (LMWH ±â€¯warfarin) for treating acute venous thromboembolism (VTE). However, guidelines suggest avoiding DOACs in those >120 kg given limited data. OBJECTIVE: To capture outcome and prescription fill data in a cohort of patients >120 kg with acute VTE out to 1 year. METHODS: Using linked administrative data, a retrospective sub-study of obese patients (>120 kg) with acute VTE discharged from institutions from 2014 to 2017 was performed. Primarily, the overall rate of recurrent VTE was assessed. Secondarily, anticoagulant regimens (agent/dosing) and bleeding events were recorded with recurrent events confirmed by chart reviews. Outcomes were compared between DOACs and traditional therapies. RESULTS: Amongst 187 patients included, the overall rate of recurrent VTE out to 1 year was 0.006 events/patient year, and the only event during the entire follow-up occurred off therapy. Throughout the year, 38.5% were prescribed a DOAC only, 32.6% were prescribed traditional therapy only and 23.5% were switched from LMWH/warfarin to a DOAC. The proportion of patients receiving sub-therapeutic, standard or supra-therapeutic regimens were: DOAC (11.1%, 85.2%, 3.7%), LMWH (24.2%, 71.0%, 4.8%), warfarin (30.4%, 55.0%, 15.0%). Bleeding occurred in 9 (8.3%) and 9 (11.5%) patients on DOAC and traditional therapy, respectively (relative risk 0.85 [95%CI 0.44-1.28]). CONCLUSIONS: More obese patients with acute VTE were prescribed DOACs than traditional therapies. Standard dosing was used for DOACs (85.2%), whereas sub-optimal dosing occurred for 25-33% receiving traditional therapies. Rates of recurrent VTE and bleeding were similar in the two groups, lending support for DOAC use in this population.

Association Between Hemoglobin A1c and Major Adverse Coronary Events in Patients with Diabetes Following Coronary Artery Bypass Surgery.

INTRODUCTION: Diabetes is associated with a higher risk of major adverse coronary events (MACE) following coronary artery bypass grafting (CABG). Guidelines recommend disparate targets for glycemic control of patients with diabetes who have undergone CABG, ranging from a target hemoglobin A1c (HbA1c) of < 7.0% to 7.1-8.5%, based on data from non-CABG patients. To date, no study has evaluated the long-term impact of HbA1c concentrations on MACE post-CABG. OBJECTIVE: To evaluate the association between HbA1c and MACE in CABG patients with diabetes. METHODS: A secondary analysis of the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI2D) trial, which enrolled patients with type 2 diabetes and coronary artery disease, restricted to participants who underwent CABG with ≥ 1 HbA1c measurement post-CABG, was performed. The index date was date of first post-CABG HbA1c measurement. The primary outcome was MACE (composite of death, myocardial infarction, unstable angina, or repeat revascularization). Secondary outcomes included MACE components and heart failure. Cox proportional hazards models treating HbA1c as a time-dependent exposure (reference group: HbA1c 6.1-7.0%) were used to derive hazard ratios (HRs) with 95% confidence intervals adjusting for age, sex and baseline characteristics selected by stepwise regression. RESULTS: A total of 549 patients were followed over a median 3.5 years. The median age of the cohort was 64 years, 25.1% were female, and median baseline HbA1c was 6.7%. Compared to achieving an HbA1c 6.1-7.0%, HbA1c > 8.0% was associated with an increased risk of MACE (HR 1.77, 1.01-3.10). This association was strongest for unstable angina (HR 5.21, 1.03-26.39). Achieving an HbA1c ≤ 6.0% was associated with an increased risk of death (HR 2.41, 1.01-5.74). Other comparisons were not statistically significant. CONCLUSION: Among patients with type 2 diabetes who underwent CABG, achieving HbA1c 6.1-7.0% was associated with a lower risk of MACE and unstable angina versus achieving an HbA1c > 8.0% and lower risk of death versus achieving an HbA1c ≤ 6.0%.